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Grand Challenges is a family of initiatives fostering innovation to solve key global health and development problems. Each initiative is an experiment in the use of challenges to focus innovation on making an impact. Individual challenges address some of the same problems, but from differing perspectives.

Rosanna PeelingLondon School of Hygiene and Tropical MedicineLondon, United Kingdom

Grand Challenges Canada

Point-of-Care Diagnostics

31 Mar 2012

Regulatory approval for diagnostics is costly, lengthy and lacks transparency in many countries. It is seen as a major barrier to innovation and access. This project seeks to survey the regulatory landscape and develop a clearly defined set of standards and a critical path for streamlining the approval of a new generation of diagnostics that are affordable, easy to use and work on plug-and-play type devices. It will work closely with product standards setters, departments of health, the diagnostic industry, regulatory authorities and regional harmonization working parties to develop a transparent model framework for rapid and efficient approval of this novel class of diagnostics, and for the harmonization of regulatory processes in the developing world to ensure that patient needs are met in all resource settings.

Grant funded by Grand Challenges Canada: Pradeep Das of Rajendra Memorial Research Institute of Medical Sciences in India will determine how to ensure that people with Visceral Leishmaniasis, a neglected infectious disease of poverty in Bihar, India, receive the necessary point­of­care diagnosis needed to receive treatment and save lives. Many people die from this disease because they do not receive the available diagnosis and treatment.

Jonathan Blackburn of the University of Cape Town in South Africa will use tuberculosis as a model disease to develop a low-cost, hand-held biosensor that combines the selectivity of antigen-specific DNA aptamers with the exceptional specificity of Surface Enhanced Raman Spectroscopy in order to reliably quantify pathogen biomarkers present in patient specimens at the point-of-care.

Achilles Katamba and investigators from Makerere University, Northwestern University, the Indian School of Business and the University of Chicago are pioneering a methodological approach to inform the design of point-of-care diagnostic platforms and create a decision support tool to enable implementation of these platforms once they become available.

Quimin You of Ustar Biotechnologies (Hangzhou) Ltd. in China will develop affordable, rapid, and simple nucleic acid extraction devices and an affordable, rapid and simple isothermal nucleic acid amplification assay that can be performed at the village level by minimally trained personnel.

Wendy Stevens of the National Health Laboratory Service and the University of Witwatersrand will lead a multi­ disciplinary team to assess the safety, cost effectiveness and impact on clinical outcome of implementing point­of care testing for HIV and tuberculosis in several different clinical settings in South Africa. The aim is to create a sustainable vehicle for future point­of­care evaluation and expansion and to provide sufficient information to inform national policy decisions, bearing in mind the need for equity, affordability and accessibility.

Chandrasekhar Nair of Bigtec Labs in India aims to create a low-cost, reliable, automated sample preparation system that can be interfaced with nucleic acid detection techniques such as real-time polymerase chain reaction (PCR) and Loop-Mediated Isothermal PCR (LAMP), thus enabling molecular diagnosis at the point-of-care. The technique involves the creation of a device to extract pathogenic DNA/RNA from biological samples such as blood, sputum, urine, and nasal/throat swabs.

Patricia Garcia of Universidad Peruana Cayetano Heredia in Peru will aim to understand the needs for point-of-care diagnostic tests for antenatal and child care in developing countries, and to develop and test a model for enhancing rapid and sustainable uptake of these tests using social and business innovation, which could have a significant impact on maternal and child health globally.